LONDON, June 6, 2008-The European Medicines Agency
has reviewed the risks associated with the use of heparin medicinal
products contaminated with oversulphated chondroitin sulphate
(OSCS). Heparins are used to prevent and treat blood clots. They
are used widely in patients who could have, or have had a heart
attack, in patients who have undergone major surgery, or patients
on dialysis.

The Agency’s Committee for Medicinal Products
for Human Use (CHMP) concluded that:

OSCS has been found in unfractionated (standard) and
low-molecular-weight heparin;

there is a link between contamination with high levels of OSCS
and serious side effects seen in some patients who have received
contaminated standard heparin. All batches of affected standard
heparin have been identified by regulatory authorities worldwide
and removed from the market;

low levels of OSCS have also been identified in some batches of
the low-molecular-weight heparin enoxaparin. However, no similar
side effects have been observed when enoxaparin has been used. A
total removal of contaminated enoxaparin from the market in
countries where it is used would lead to a shortage of supply and
patients would not be able to continue their treatment.

The Committee concluded that doctors can continue
to use enoxaparin with low levels of OSCS to treat patients
temporarily until the situation is resolved. However, a series of
measures should be put in place to minimise the risk of side
effects. These include:

as a precautionary measure, avoiding administration to pregnant
women if alternative products or uncontaminated enoxaparin are
available.

The CHMP also looked at long-term approaches to
minimise the possibility of future contamination. It recommended
any inspection of the heparin supply-chain requires a coordinated
approach between European and international partners and that
modifications to the existing legal and regulatory framework for
strengthening the supply-chain control should be explored with the
European Commission;

Specific tests for OSCS and other possible
contaminants should be included in the heparin monographs in the
European Pharmacopoeia.

Heparin medicines are authorised at the level of
the Member States. Country-specific advice and information on
stocks and potential shortages are available in all affected Member
States.

-- ENDS --

Notes:

1. More information is available in a question-and-answer
document.

2. The review was initiated by Germany under Article 5(3) of
Regulation (EC) No 726/2004 following detection of a contaminant in
a limited number of batches in some Member States of the European
Union.

3. This press release, together with other information on the
work of the EMEA, can be found on the EMEA website:
www.emea.europa.eu